EP4236922A1 - Non-effervescent dissolvable tablets comprising hmos - Google Patents

Non-effervescent dissolvable tablets comprising hmos

Info

Publication number
EP4236922A1
EP4236922A1 EP21798691.8A EP21798691A EP4236922A1 EP 4236922 A1 EP4236922 A1 EP 4236922A1 EP 21798691 A EP21798691 A EP 21798691A EP 4236922 A1 EP4236922 A1 EP 4236922A1
Authority
EP
European Patent Office
Prior art keywords
tablet
fast
total weight
fast dissolvable
present
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP21798691.8A
Other languages
German (de)
French (fr)
Inventor
Zhenbo Ma
Conroy Clive SALMON
Paulo Henrique SANTOS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DSM IP Assets BV
Original Assignee
DSM IP Assets BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by DSM IP Assets BV filed Critical DSM IP Assets BV
Publication of EP4236922A1 publication Critical patent/EP4236922A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2250/00—Food ingredients
    • A23V2250/28—Oligosaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Definitions

  • the present invention relates to a new formulation (a tablet) comprising Human Milk Oligosaccharides (HMOs), which dissolves or can be dispersed in water (or water based liquids) fast.
  • HMOs Human Milk Oligosaccharides
  • the tablets are when dissolved can be consumed easily by a human.
  • HMOs are often used in infant formula. There are many other known formulations for HMOs (powders, tablets, capsules etc).
  • the present invention relates to new way to deliver HMOs.
  • the form is a specific non- effervescent fast dissolvable tablet.
  • Effervescent or carbon tablets are tablets which dissolve in water (or water based liquids) and release carbon dioxide. Such tablets are products of compression of component ingredients in the form of powders into a dense mass, which is packaged in blister pack, or with a hermetically sealed package with incorporated desiccant in the cap. To use them, they are dropped into water (or water-based liquids) to make a solution.
  • Effervescent tablets have some advantages over regular tablets, such as the following:
  • Effervescent tablets are popular due to the fact they can be dissolved in a liquid such as water or fruit juice, meaning that they often taste better than regular tablets. Conventional tablets dissolve slowly which can result in reduced absorption rates, effervescent tablets, in contrast, dissolve quickly and completely, meaning you get the full benefit from the ingredients.
  • Effervescent tablets provide the nutritional benefits intended, but in addition to this they also increase liquid intake. This can be especially beneficial if you are dehydrated or ill and not ingesting as much fluid as usual. Effervescent tablets can be a fantastic way of rehydrating as well as reaping the benefits you are taking the tablets for whether this is a dietary supplement.
  • effervescent tablets can be a lot easier than having to swallow a tablet.
  • Effervescent tablets are easily dissolved into water or a liquid of your choice and then after a while are consistent, well mixed and ready to drink. Traditional tablets or powders, however, need to be measured and stirred in repeatedly to avoid an inconsistent drink with lumpy bits.
  • the primary material used in the manufacture of effervescent tablets is relatively hygroscopic, that is, it absorbs moisture from the air. However, this must be prevented because it will initiate the effervescent reaction.
  • One of the principle strategies used to overcome this problem is a completely closed material handling system during production,
  • the tablets need to be packed in such a way that it that moisture cannot harm the tablet during storage before use.
  • the present invention relates to a non-effervescent (water) fast dissolvable tablet (DS), which comprises
  • the dissolution rate of the tablet according to the present invention is excellent.
  • the tablet according to the present invention dissolves in a water-based liquid in similar rate as an effervescent tablet. No additional vigorous shaking, stirring or other means are necessary to achieve a complete dissolution in an acceptable time.
  • the size of the tablet according to the present invention can vary.
  • the size is more or less the same as a conventional effervescent tablet.
  • the typical and preferred size is usually chosen that the amount of the HMOs and of any other used physiologically active ingredient is enough to cover the daily recommended or any desired amount.
  • the shape of the tablet according to the present invention is not an essential feature. But usually it has a disc-like shape having a diameter of up to 3 cm (preferably 1.5 - 2.5 cm) and a thickness of up to 0.8 cm (preferably 0.3 - 0.6 cm) and it has a weight of up to 5 g (preferably 0.2 - 5g).
  • the present invention relates to a fast dissolvable tablet DS1 , which is fast dissolvable tablet DS, wherein the tablet has a disc-like shape.
  • the present invention relates to a fast dissolvable tablet DST, which is fast dissolvable tablet DS1 , wherein the tablet has a diameter of up to 3 cm (preferably 1.5 - 2.5 cm) and a thickness of up to 0.8cm (preferably 0.3 - 0.6cm).
  • the present invention relates to a fast dissolvable tablet DS2, which is fast dissolvable tablet DS, DS1 or DST, wherein the tablet has a weight of up to 5 g (preferably 0.2 - 5g).
  • the tablet according to the present invention is dissolved or dispersed in a glass of water (or water based liquid), which is usually between 0.1 - 0.4 liter.
  • the tablets according to the present invention dissolved rapidly. It has similar dissolving properties as a usual effervescent tablets.
  • the dissolving time is less than 4 minutes (or even less than 2 minutes).
  • the tablet according to the present invention is soluble in pure water as well as in waterbased solvents. This means the tablet according to the present invention can also be dissolved in any water based liquid (such as fruit juices, milk, smoothies, etc).
  • the liquid can be cold or hot.
  • the liquid can be carbonated or non-carbonated.
  • Preferred embodiments according to the present inventions are fast dissolvable tablets comprises 0.1 - 40 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
  • fast dissolvable tablets comprises 5 - 35 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
  • fast dissolvable tablets comprises 10 - 35 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
  • the present invention relates to a fast dissolvable tablet DS3, which is fast dissolvable tablet DS, DS1 , DS1 ’ or DS2, wherein the tablet comprises 0.1 - 50 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
  • the present invention relates to a fast dissolvable tablet DS3’, which is fast dissolvable tablet DS, DS1 , DS1’ or DS2, wherein the tablet comprises 5 - 35 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
  • the present invention relates to a fast dissolvable tablet DS3”, which is fast dissolvable tablet DS, DS1 , DS1’ or DS2, wherein the tablet comprises 10 - 35 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
  • HMOs Human milk oligosaccharides
  • HMOs are composed of the five monosaccharides glucose (Glc), galactose (Gal), N- acetylglucosamine (GIcNAc), fucose (Fuc) and sialic acid (Sia), with N-acetylneuraminic acid (Neu5Ac) as the predominant if not only form of Sia. More than two hundred different HMOs have been identified so far.
  • HMOs can be isolated from breast milk or they can be produced chemically or biochemically. HMOs are available commercially from a variety of producers.
  • the source of the HMO is not essential. It is clear that HMOs from different sources can be used.
  • the present invention relates to a fast dissolvable tablet DS4, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, or DS3”, wherein the at least one HMO is chosen from the group consisting of 2'-fucosyllactose (2' FL), lacto-N-neotetraose (LNnT), 3-fucosyllactose (3FL), difucosyl-lactose (DFL), Lacto-N-fucopentaose I (LNFP I), 3'Sialyllactose Sodium Salt (3'SL), 6'Sialyllactose Sodium Salt (6'SL), and Lacto-N- Tetraose (LNT).
  • 2'-fucosyllactose 2' FL
  • lacto-N-neotetraose LNnT
  • 3-fucosyllactose 3FL
  • DFL d
  • Such suitable additional active ingredients are vitamins, carotenoids, minerals, and any other dietary ingredient.
  • the present invention relates to a fast dissolvable tablet DS5, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, or DS3” or DS4, wherein the tablet according to the present invention can also comprise at least one additional active ingredient.
  • the present invention relates to a fast dissolvable tablet DS5’, which is fast dissolvable tablet DS5, wherein the additional active ingredient is chosen from the group consisting of vitamins, carotenoids, minerals, and any other dietary ingredient.
  • the amount of the additional active ingredient can be up to 25 wt-%, based on the total weight of the fast dissolvable tablet (usually up to 15 wt-%).
  • the active ingredients used in the tablet according to the present invention can be used in pure form as well as in preformulated form (which means that one or more active ingredient is formulated before used in the production of the tablet according to the present invention).
  • the vitamins according to the present invention can be fat-soluble as well as water-soluble.
  • the fat-soluble vitamins are selected from the group consisting of vitamin A, D, E and K. These vitamins are usually used as preformulated form in the tablet.
  • the water-soluble vitamins are selected from the group consisting of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin, niacinamide), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine, pyridoxamine, pyridoxal), vitamin B7 (biotin), vitamin B9 (folic acid, folinic acid), vitamin B12 (cyanocobalamin, hydroxycobalamin, methylcobalamin), and vitamin C (ascorbic acid).
  • vitamin B1 thiamine
  • vitamin B2 riboflavin
  • vitamin B3 niacin, niacinamide
  • vitamin B5 pantothenic acid
  • vitamin B6 pyridoxine, pyridoxamine, pyridoxal
  • vitamin B7 biotin
  • vitamin B9 folic acid, folinic acid
  • vitamin B12 cyanocobalamin, hydroxycobalamin, methylcobalamin
  • vitamin C ascorbic acid
  • Carotenoids are chosen form the group consisting of beta-carotene, lycopene, lutein, bixin, astaxanthin, apocarotenal, beta-apo-8’-carotenal, beta-apo-12’-carotenal, can- thaxanthin, cryptoxanthin, citranaxanthin and zeaxanthin. These carotenoids are usually used as preformulated form in the tablet.
  • the minerals are chosen from the group consisting of minerals, which are added to the formulation are Sodium, Potassium, Calcium, Iron, Zinc, and Magnesium.
  • a suitable trace element is for example iodine.
  • the present invention relates to a fast dissolvable tablet DS6, which is the fast dissolvable tablet DS5 or DS5’, wherein the at least active ingredient is chosen from the group consisting of vitamins chosen from the group consisting of vitamin A, vitamin D (vitamin D3), vitamin E, vitamin K1 , vitamin K2, vitamin B1 , vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, and vitamin C; and/or from carotenoids chosen from the group consisting of beta-carotene, lycopene, lutein, bixin, astaxanthin, apocarotenal, beta-apo-8’-carotenal, beta-apo-12’-carotenal, canthaxanthin, cryptoxanthin, citranaxanthin and zeaxanthin; and/or from minerals chosen from the group consisting of Sodium, Potassium, Calcium, Iron, Zinc, and Magnesium and/or any other dietary ingredient (such as trace elements, plant extract
  • a preferred embodiment of the present invention is as fast dissolvable tablet comprising 25 - 90 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent.
  • a more preferred embodiment of the present invention is as fast dissolvable tablet comprising 30 - 80 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent.
  • Suitable diluents are sugar alcohols such as mannitol, sorbitol, xylitol and disaccharides such as sucrose or lactose.
  • the present invention relates to a fast dissolvable tablet DS7, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’ or DS6, wherein the tablet comprises 25 -90 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent.
  • the present invention relates to a fast dissolvable tablet DS7’, which is fast dissolvable tablet DS7, wherein the tablet comprises 30 - 80 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent.
  • Suitable diluents are sugar alcohols such as mannitol, sorbitol, xylitol and disaccharides such as sucrose or lactose.
  • the present invention relates to a fast dissolvable tablet DS8, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’, DS6, DS7 or DS7’, wherein the least one diluent is chosen from the group consisting of sugar alcohols (such as mannitol, sorbitol and xylitol) and disaccharides (such as sucrose and lactose).
  • a preferred embodiment of the present invention is as fast dissolvable tablet comprising 3 - 45 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disin- tegrant.
  • a more preferred embodiment of the present invention is as fast dissolvable tablet comprising 15 - 40 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disintegrant.
  • Suitable disintegrant are starch, crospovidone (cross linked polyvinyl N-pyrrolidone), coprocessed sugar alcohol with starch, croscarmellose Sodium, and sodium starch glycolate.
  • the present invention relates to a fast dissolvable tablet DS9, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’, DS6, DS7, DS7’, or DS8, wherein the tablet comprises 10 - 45 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disintegrant.
  • the present invention relates to a fast dissolvable tablet DS9’, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’, DS6, DS7, DS7’ or DS8, wherein the tablet comprises 15 - 40 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disintegrant.
  • the present invention relates to a fast dissolvable tablet DS10, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’, DS6, DS7, DS7’, DS8, DS9 or DS9’, wherein the at least one disintegrant is chosen from the group consisting of starches, crospovidone (cross linked polyvinyl N-pyrrolidone), co-processed sugar alcohol with starch, croscarmellose Sodium, and sodium starch glycolate.
  • crospovidone cross linked polyvinyl N-pyrrolidone
  • co-processed sugar alcohol with starch croscarmellose Sodium
  • sodium starch glycolate sodium starch glycolate
  • the tablet according to the present invention can comprise further ingredients (auxiliary agents), such as flavours, colours, fillers, lubricants, and sweeteners.
  • auxiliary agents such as flavours, colours, fillers, lubricants, and sweeteners.
  • These ingredients are not essential for the invention, but they are useful to design a tablet, which is useful for the desired aim of the tablet.
  • Such ingredients can be present in the tablets according to the present invention in amount of up to 15 wt-%, based on the total weight of the tablet.
  • the present invention relates to a fast dissolvable tablet DS11 , which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’, DS6, DS7, DS7’, DS8, DS9, DS9’ or DS10, wherein the tablet comprises at least one auxiliary agent chosen from the group consisting of, flavours, colours, fillers, lubricants and sweetener.
  • the present invention relates to a fast dissolvable tablet DS11’, which is fast dissolvable tablet DS11 , wherein the tablet comprises 2 - 15 wt-% (preferably 3 - 12 wt- %), based on the total weight of the tablet, of at least one auxiliary agent.
  • a preferred embodiment of the present invention is a tablet, wherein the carbonate content is below 0.5 wt-%, based on the total weight of the tablet.
  • a more preferred embodiment of the present invention is a tablet, wherein the carbonate content is below 0.3 wt-%, based on the total weight of the tablet.
  • Especially preferred embodiment of the present invention is a tablet which is essentially free of any carbonate. This means that the tablet does not comprise any carbonate. This means that no carbonate is added to the tablet.
  • the present invention relates to a fast dissolvable tablet DS12, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS6, DS6’, DS7, DS8, DS8’, DS9, DS10, DS10’ or DS11 , wherein the tablet comprises less than 0.5 wt-%, based on the total weight of the tablet, of carbonate.
  • the present invention relates to a fast dissolvable tablet DS12’, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS6, DS6’, DS7, DS8, DS8’, DS9, DS10, DS10’ or DS11 , wherein the tablet comprises less than 0.3 wt-%, based on the total weight of the tablet, of carbonate.
  • the present invention relates to a fast dissolvable tablet DS12”, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS6, DS6’, DS7, DS8, DS8’, DS9, DS10, DS10’ or DS11 , wherein the tablet is essentially free of any carbonate.
  • the tablets according to the present invention can be produced by using commonly known processes.
  • the pressing can be done by commonly known and used equipment, such as a “D” type rotary press.
  • a suitable and ideal tablet according to the present invention has a hardness of around 5kp to 20kp, preferably 5kp - 15kp.
  • the present invention relates to a fast dissolvable tablet DS13, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS6, DS6’, DS7, DS8, DS8’, DS9, DS10, DS10’ or DS11 , DS12, DS12’ or DS12”, wherein the tablet is essentially free of any carbonate.
  • the tablet (depending on the choice of active ingredients) can be used as dietary supplements.
  • the tablets can be packed and sold in any commonly used container for tablet, due to the good storage stability.
  • step 3 Add sieved lubricant into step 2 and mix for 5 mins.
  • This tablet has been dropped in about 236 ml (8 oz) of water and was shaken gently.
  • the tablet was dissolved rapidly and completely within 2 mins.
  • step 3 Add sieved lubricant into step 2 and mix for 3 mins.
  • This tablet has been dropped in about 236 ml (8 oz) of water and was shaken gently.
  • the tablet was dissolved rapidly and completely within 2 mins.

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Abstract

The present invention relates to a new formulation (a non-effervescent tablet) comprising Human Milk Oligosaccharides (HMOs), which dissolves or can be dispersed in water (or water based liquids) fast. The tablets are when dissolved can be consumed easily by a human.

Description

Non-Effervescent Dissolvable Tablets Comprising HMOs
The present invention relates to a new formulation (a tablet) comprising Human Milk Oligosaccharides (HMOs), which dissolves or can be dispersed in water (or water based liquids) fast. The tablets are when dissolved can be consumed easily by a human.
HMOs are often used in infant formula. There are many other known formulations for HMOs (powders, tablets, capsules etc).
The present invention relates to new way to deliver HMOs. The form is a specific non- effervescent fast dissolvable tablet.
Effervescent or carbon tablets are tablets which dissolve in water (or water based liquids) and release carbon dioxide. Such tablets are products of compression of component ingredients in the form of powders into a dense mass, which is packaged in blister pack, or with a hermetically sealed package with incorporated desiccant in the cap. To use them, they are dropped into water (or water-based liquids) to make a solution.
Effervescent tablets have some advantages over regular tablets, such as the following:
• Pleasant taste compared to regular tablets
Effervescent tablets are popular due to the fact they can be dissolved in a liquid such as water or fruit juice, meaning that they often taste better than regular tablets. Conventional tablets dissolve slowly which can result in reduced absorption rates, effervescent tablets, in contrast, dissolve quickly and completely, meaning you get the full benefit from the ingredients.
• Distributed more evenly
Conventional tablets dissolve gradually in the stomach once ingested and can sometimes only partially dissolve which can lead to irritation in some cases. The benefit of effervescent tablets is that they dissolve completely and evenly meaning that localised concentrations of the ingredients cannot occur. This means not only a better taste but also less chance of irritation and a more efficient means of ingesting the ingredients.
• Increased liquid intake
Effervescent tablets provide the nutritional benefits intended, but in addition to this they also increase liquid intake. This can be especially beneficial if you are dehydrated or ill and not ingesting as much fluid as usual. Effervescent tablets can be a fantastic way of rehydrating as well as reaping the benefits you are taking the tablets for whether this is a dietary supplement.
• Easy alternative to regular tablets
They can be a great alternative for those who may have trouble swallowing either due to illness or age. Older individuals may have difficulty swallowing but need to take medication or supplements on a regular basis and in this respect, effervescent tablets can be a lot easier than having to swallow a tablet.
• Simple and easy to measure
Effervescent tablets are easily dissolved into water or a liquid of your choice and then after a while are consistent, well mixed and ready to drink. Traditional tablets or powders, however, need to be measured and stirred in repeatedly to avoid an inconsistent drink with lumpy bits.
All these factors combine to make effervescent tablets a very popular choice for those taking tablets for either dietary supplementation or medicinal reasons. Besides these advantages, there are also some major disadvantages of effervescent tablets, such as a complex production process and, very often, the need for special packaging materials for achieving a good storage stability.
The primary material used in the manufacture of effervescent tablets is relatively hygroscopic, that is, it absorbs moisture from the air. However, this must be prevented because it will initiate the effervescent reaction. One of the principle strategies used to overcome this problem is a completely closed material handling system during production,
Furthermore, the tablets need to be packed in such a way that it that moisture cannot harm the tablet during storage before use.
Therefore, the present invention relates to a non-effervescent (water) fast dissolvable tablet (DS), which comprises
(a) 0.1 - 50 weight-% (wt-%), based on the total weight of the fast dissolvable tablet, of at least one human milk oligosaccharide, and
(b) 20 - 95 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent, and
(c) 2 - 50 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disintegrant, and wherein the content of any carbonate is below 1 wt-%, based on the total weight of the fast dissolvable tablet.
All percentages are always added up to 100 in total (in one embodiment of a tablet according to the present invention).
The dissolution rate of the tablet according to the present invention is excellent. The tablet according to the present invention dissolves in a water-based liquid in similar rate as an effervescent tablet. No additional vigorous shaking, stirring or other means are necessary to achieve a complete dissolution in an acceptable time.
The size of the tablet according to the present invention can vary. The size is more or less the same as a conventional effervescent tablet. The typical and preferred size is usually chosen that the amount of the HMOs and of any other used physiologically active ingredient is enough to cover the daily recommended or any desired amount.
The shape of the tablet according to the present invention is not an essential feature. But usually it has a disc-like shape having a diameter of up to 3 cm (preferably 1.5 - 2.5 cm) and a thickness of up to 0.8 cm (preferably 0.3 - 0.6 cm) and it has a weight of up to 5 g (preferably 0.2 - 5g).
Therefore the present invention relates to a fast dissolvable tablet DS1 , which is fast dissolvable tablet DS, wherein the tablet has a disc-like shape.
Therefore the present invention relates to a fast dissolvable tablet DST, which is fast dissolvable tablet DS1 , wherein the tablet has a diameter of up to 3 cm (preferably 1.5 - 2.5 cm) and a thickness of up to 0.8cm (preferably 0.3 - 0.6cm).
Therefore the present invention relates to a fast dissolvable tablet DS2, which is fast dissolvable tablet DS, DS1 or DST, wherein the tablet has a weight of up to 5 g (preferably 0.2 - 5g).
Usually the tablet according to the present invention is dissolved or dispersed in a glass of water (or water based liquid), which is usually between 0.1 - 0.4 liter.
The tablets according to the present invention dissolved rapidly. It has similar dissolving properties as a usual effervescent tablets.
The dissolving time is less than 4 minutes (or even less than 2 minutes)..
The tablet according to the present invention is soluble in pure water as well as in waterbased solvents. This means the tablet according to the present invention can also be dissolved in any water based liquid (such as fruit juices, milk, smoothies, etc). The liquid can be cold or hot. The liquid can be carbonated or non-carbonated. Preferred embodiments according to the present inventions are fast dissolvable tablets comprises 0.1 - 40 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
More preferred embodiments according to the present inventions are fast dissolvable tablets comprises 5 - 35 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
Especially preferred embodiments according to the present inventions are fast dissolvable tablets comprises 10 - 35 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
Therefore the present invention relates to a fast dissolvable tablet DS3, which is fast dissolvable tablet DS, DS1 , DS1 ’ or DS2, wherein the tablet comprises 0.1 - 50 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
Therefore the present invention relates to a fast dissolvable tablet DS3’, which is fast dissolvable tablet DS, DS1 , DS1’ or DS2, wherein the tablet comprises 5 - 35 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
Therefore the present invention relates to a fast dissolvable tablet DS3”, which is fast dissolvable tablet DS, DS1 , DS1’ or DS2, wherein the tablet comprises 10 - 35 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
Human milk oligosaccharides (HMOs) are a family of structurally diverse unconjugated glycans that are highly abundant in and unique to human milk. Originally, HMOs were proposed to be prebiotic "bifidus factors," or human milk glycans found to promote growth in Bifidobacterial species of the gut and found uniquely in the stool of breast fed infants compared to formula fed infants.
HMOs are composed of the five monosaccharides glucose (Glc), galactose (Gal), N- acetylglucosamine (GIcNAc), fucose (Fuc) and sialic acid (Sia), with N-acetylneuraminic acid (Neu5Ac) as the predominant if not only form of Sia. More than two hundred different HMOs have been identified so far. The most important ones are 2'-fucosyllactose (2' FL), lacto-N-neotetraose (LNnT), 3-fucosyllactose (3FL), difucosyllactose (DFL), Lacto-N-fu- copentaose I (LNFP I), 3'Sialyllactose Sodium Salt (3'SL), 6'Sialyllactose Sodium Salt (6'SL), and Lacto-N-Tetraose (LNT).
HMOs can be isolated from breast milk or they can be produced chemically or biochemically. HMOs are available commercially from a variety of producers.
For the purpose of the present invention the source of the HMO is not essential. It is clear that HMOs from different sources can be used.
Therefore the present invention relates to a fast dissolvable tablet DS4, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, or DS3”, wherein the at least one HMO is chosen from the group consisting of 2'-fucosyllactose (2' FL), lacto-N-neotetraose (LNnT), 3-fucosyllactose (3FL), difucosyl-lactose (DFL), Lacto-N-fucopentaose I (LNFP I), 3'Sialyllactose Sodium Salt (3'SL), 6'Sialyllactose Sodium Salt (6'SL), and Lacto-N- Tetraose (LNT).
It is also possible to add other active ingredient to the tablet according to the present invention. Such active ingredients are usually used in common effervescent tablets.
Such suitable additional active ingredients are vitamins, carotenoids, minerals, and any other dietary ingredient.
Therefore the present invention relates to a fast dissolvable tablet DS5, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, or DS3” or DS4, wherein the tablet according to the present invention can also comprise at least one additional active ingredient.
Therefore the present invention relates to a fast dissolvable tablet DS5’, which is fast dissolvable tablet DS5, wherein the additional active ingredient is chosen from the group consisting of vitamins, carotenoids, minerals, and any other dietary ingredient.
The amount of the additional active ingredient can be up to 25 wt-%, based on the total weight of the fast dissolvable tablet (usually up to 15 wt-%). The active ingredients used in the tablet according to the present invention can be used in pure form as well as in preformulated form (which means that one or more active ingredient is formulated before used in the production of the tablet according to the present invention).
The vitamins according to the present invention can be fat-soluble as well as water-soluble.
The fat-soluble vitamins are selected from the group consisting of vitamin A, D, E and K. These vitamins are usually used as preformulated form in the tablet.
The water-soluble vitamins are selected from the group consisting of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin, niacinamide), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine, pyridoxamine, pyridoxal), vitamin B7 (biotin), vitamin B9 (folic acid, folinic acid), vitamin B12 (cyanocobalamin, hydroxycobalamin, methylcobalamin), and vitamin C (ascorbic acid).
Carotenoids are chosen form the group consisting of beta-carotene, lycopene, lutein, bixin, astaxanthin, apocarotenal, beta-apo-8’-carotenal, beta-apo-12’-carotenal, can- thaxanthin, cryptoxanthin, citranaxanthin and zeaxanthin. These carotenoids are usually used as preformulated form in the tablet.
The minerals are chosen from the group consisting of minerals, which are added to the formulation are Sodium, Potassium, Calcium, Iron, Zinc, and Magnesium.
A suitable trace element is for example iodine.
Therefore the present invention relates to a fast dissolvable tablet DS6, which is the fast dissolvable tablet DS5 or DS5’, wherein the at least active ingredient is chosen from the group consisting of vitamins chosen from the group consisting of vitamin A, vitamin D (vitamin D3), vitamin E, vitamin K1 , vitamin K2, vitamin B1 , vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, and vitamin C; and/or from carotenoids chosen from the group consisting of beta-carotene, lycopene, lutein, bixin, astaxanthin, apocarotenal, beta-apo-8’-carotenal, beta-apo-12’-carotenal, canthaxanthin, cryptoxanthin, citranaxanthin and zeaxanthin; and/or from minerals chosen from the group consisting of Sodium, Potassium, Calcium, Iron, Zinc, and Magnesium and/or any other dietary ingredient (such as trace elements, plant extract etc).
A preferred embodiment of the present invention is as fast dissolvable tablet comprising 25 - 90 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent.
A more preferred embodiment of the present invention is as fast dissolvable tablet comprising 30 - 80 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent.
Suitable diluents are sugar alcohols such as mannitol, sorbitol, xylitol and disaccharides such as sucrose or lactose.
Therefore the present invention relates to a fast dissolvable tablet DS7, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’ or DS6, wherein the tablet comprises 25 -90 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent.
Therefore the present invention relates to a fast dissolvable tablet DS7’, which is fast dissolvable tablet DS7, wherein the tablet comprises 30 - 80 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent.
Suitable diluents are sugar alcohols such as mannitol, sorbitol, xylitol and disaccharides such as sucrose or lactose.
Therefore the present invention relates to a fast dissolvable tablet DS8, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’, DS6, DS7 or DS7’, wherein the least one diluent is chosen from the group consisting of sugar alcohols (such as mannitol, sorbitol and xylitol) and disaccharides (such as sucrose and lactose). A preferred embodiment of the present invention is as fast dissolvable tablet comprising 3 - 45 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disin- tegrant.
A more preferred embodiment of the present invention is as fast dissolvable tablet comprising 15 - 40 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disintegrant.
Suitable disintegrant are starch, crospovidone (cross linked polyvinyl N-pyrrolidone), coprocessed sugar alcohol with starch, croscarmellose Sodium, and sodium starch glycolate.
Therefore the present invention relates to a fast dissolvable tablet DS9, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’, DS6, DS7, DS7’, or DS8, wherein the tablet comprises 10 - 45 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disintegrant.
Therefore the present invention relates to a fast dissolvable tablet DS9’, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’, DS6, DS7, DS7’ or DS8, wherein the tablet comprises 15 - 40 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disintegrant.
Therefore the present invention relates to a fast dissolvable tablet DS10, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’, DS6, DS7, DS7’, DS8, DS9 or DS9’, wherein the at least one disintegrant is chosen from the group consisting of starches, crospovidone (cross linked polyvinyl N-pyrrolidone), co-processed sugar alcohol with starch, croscarmellose Sodium, and sodium starch glycolate.
Furthermore the tablet according to the present invention can comprise further ingredients (auxiliary agents), such as flavours, colours, fillers, lubricants, and sweeteners. These ingredients are not essential for the invention, but they are useful to design a tablet, which is useful for the desired aim of the tablet. Such ingredients can be present in the tablets according to the present invention in amount of up to 15 wt-%, based on the total weight of the tablet.
Usually when they are used they are present in an amount of 2 - 15 wt-% (preferably 3 - 12 wt-%), based on the total weight of the tablet.
Therefore the present invention relates to a fast dissolvable tablet DS11 , which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS5’, DS6, DS7, DS7’, DS8, DS9, DS9’ or DS10, wherein the tablet comprises at least one auxiliary agent chosen from the group consisting of, flavours, colours, fillers, lubricants and sweetener.
Therefore the present invention relates to a fast dissolvable tablet DS11’, which is fast dissolvable tablet DS11 , wherein the tablet comprises 2 - 15 wt-% (preferably 3 - 12 wt- %), based on the total weight of the tablet, of at least one auxiliary agent.
Furthermore a preferred embodiment of the present invention is a tablet, wherein the carbonate content is below 0.5 wt-%, based on the total weight of the tablet.
A more preferred embodiment of the present invention is a tablet, wherein the carbonate content is below 0.3 wt-%, based on the total weight of the tablet.
Especially preferred embodiment of the present invention is a tablet which is essentially free of any carbonate. This means that the tablet does not comprise any carbonate. This means that no carbonate is added to the tablet.
Therefore the present invention relates to a fast dissolvable tablet DS12, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS6, DS6’, DS7, DS8, DS8’, DS9, DS10, DS10’ or DS11 , wherein the tablet comprises less than 0.5 wt-%, based on the total weight of the tablet, of carbonate.
Therefore the present invention relates to a fast dissolvable tablet DS12’, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS6, DS6’, DS7, DS8, DS8’, DS9, DS10, DS10’ or DS11 , wherein the tablet comprises less than 0.3 wt-%, based on the total weight of the tablet, of carbonate. Therefore the present invention relates to a fast dissolvable tablet DS12”, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS6, DS6’, DS7, DS8, DS8’, DS9, DS10, DS10’ or DS11 , wherein the tablet is essentially free of any carbonate.
The tablets according to the present invention can be produced by using commonly known processes.
Usually the following process steps are used
(i) Mixing all ingredients (except the lubricants) and blend them
(ii) Adding the lubricant(s) and mixing all ingredients
(iii) Pressing the mixture into a tablet form which is wished.
The pressing can be done by commonly known and used equipment, such as a “D” type rotary press.
A suitable and ideal tablet according to the present invention has a hardness of around 5kp to 20kp, preferably 5kp - 15kp.
Therefore the present invention relates to a fast dissolvable tablet DS13, which is fast dissolvable tablet DS, DS1 , DST, DS2, DS3, DS3’, DS3”, DS4, DS5, DS6, DS6’, DS7, DS8, DS8’, DS9, DS10, DS10’ or DS11 , DS12, DS12’ or DS12”, wherein the tablet is essentially free of any carbonate.
The tablet (depending on the choice of active ingredients) can be used as dietary supplements.
The tablets can be packed and sold in any commonly used container for tablet, due to the good storage stability.
The following examples serve to illustrate the invention. Examples
Example 1
Tablets of the following compositions (table 1 and Table 2) has been produced:
Table 1 :
Table 2:
The tablets with the composition of table 1 and table 2 and has been produced by the following procedure: 1. Sieve all ingredients through a 20 mesh screen.
2. Mix all ingredients except the lubricant in a V shaped blender for 10 mins.
3. Add sieved lubricant into step 2 and mix for 5 mins.
4. Produce tablets on a carver hydraulic press equipped with 1" round flat faced and bevel edged toolings.
Compression force 2000 - 3500 PSI, Tablet hardness 6-9 kp
This tablet has been dropped in about 236 ml (8 oz) of water and was shaken gently.
The tablet was dissolved rapidly and completely within 2 mins.
Example 2
Tablets of the following compositions (table 3 and table 4) have been produced:
Table 3:
Table 4:
The tablets with the composition of table 3 and table 4 and has been produced by the following procedure:
1. Sieve all ingredients through a 20 mesh screen.
2. Mix all ingredients except the lubricant in a V shaped blender for 10 mins.
3. Add sieved lubricant into step 2 and mix for 3 mins.
4. Produce tablets on a Piccola "D" rotary press equipped with 1" round flat faced and bevel edged toolings.
Table 3 example: Compression force 6000 Lbs, Tablet hardness ~8 kp, 48 rpm
Table 4 example: Compression force 4000 Lbs, Tablet hardness ~6 kp, 48 rpm
This tablet has been dropped in about 236 ml (8 oz) of water and was shaken gently.
The tablet was dissolved rapidly and completely within 2 mins.

Claims

Claims
1. A fast dissolvable tablet , which comprises
(a) 0.1 - 50 weight-% (wt-%), based on the total weight of the fast dissolvable tablet, of at least one HMO, and
(b) 20 - 95 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent, and
(c) 2 - 50 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disintegrant, and wherein the content of any carbonate is below 1 wt-%, based on the total weight of the fast dissolvable tablet.
2. Tablet according to claim 1 , wherein the tablet has a disc-like shape.
3. Tablet according to any of the preceding claims comprising 1 - 40 wt-%, based on the total weight of the fast dissolvable tablet, of at least one HMO.
4. Tablet according to any of the preceding claims, wherein the at least HMO is chosen from the group consisting of 2'-fucosyllactose (2' FL), lacto-N-neotetraose (LNnT), 3- fucosyllactose (3FL), difucosyl-lactose (DFL), Lacto-N-fucopentaose I (LNFP I), 3'Sialyl- lactose Sodium Salt (3'SL), 6'Sialyllactose Sodium Salt (6'SL), and Lacto-N-Tetraose (LNT).
5. Tablet according to any of the preceding claims comprising an additional active ingredient (preferably chosen from the group consisting of vitamins, carotenoids, minerals and any other dietary ingredient).
6. Tablet according to any of the preceding claims comprising 25 -90 wt-%, based on the total weight of the fast dissolvable tablet, of at least one diluent.
7. Tablet according to any of the preceding claims, wherein the least one diluent is chosen from the group consisting of sugar alcohols (such as mannitol, sorbitol and xylitol) and disaccharides (such as sucrose and lactose).
8. Tablet according to any of the preceding claims comprising 10 - 45 wt-%, based on the total weight of the fast dissolvable tablet, of at least one disintegrant.
9. Tablet according to any of the preceding claims, wherein the at least one disintegrant is chosen from the group consisting of starches, crospovidone (cross linked polyvinyl N-pyrrolidone), co-processed sugar alcohol with starch, croscarmellose Sodium, and sodium starch glycolate.
10. Tablet according to any of the preceding claims, wherein the tablet comprises at least one auxiliary agent chosen from the group consisting of, flavours, colours, fillers, lubricants and sweetener.
11. Tablet according to any of the preceding claims, wherein the carbonate content is below 0.5 wt-%, based on the total weight of the tablet.
12. T ablet according to any of the preceding claims, wherein the tablet which is essentially free of any carbonate.
13. T ablet according to any of the preceding claims, wherein the tablet has a hardness of about 5 to 20 kp.
EP21798691.8A 2020-10-30 2021-10-25 Non-effervescent dissolvable tablets comprising hmos Withdrawn EP4236922A1 (en)

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